Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000615280
Ethics application status
Approved
Date submitted
17/07/2009
Date registered
22/07/2009
Date last updated
11/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
FINESSE Trial – Filtration In the Neuropathy of End Stage kidney disease Symptom Evolution
Scientific title
Haemodiafiltration vs high-flux standard dialysis for uraemic neuropathy in people with end stage kidney disease
Universal Trial Number (UTN)
Trial acronym
FINESSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uraemic neuropathy 237282 0
End Stage Kidney Disease 237308 0
Condition category
Condition code
Renal and Urogenital 239610 239610 0 0
Kidney disease
Other 239656 239656 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Haemodiafiltration
Haemodiafiltration differs from conventional haemodialysis in employing convection as well as diffusion principles to remove solutes and excess water.
Participants will receive their routine haemodialysis hours and sessions (as prescribed by their treating nephrologist) with haemodiafiltration.
Intervention code [1] 236962 0
Treatment: Other
Comparator / control treatment
Standard Haemodialysis with High-flux membranes
Standard haemodialysis relies on diffusion of solutes and water across a semi-permeable membrane down a gradiant. ‘High-flux’ membranes with greater permeability for higher molecular weight molecules have been developed to enhance solute clearance and are increasingly employed.
Participants will receive their routine haemodialysis hours and sessions (as prescribed by their treating nephrologist) with standard haemodialysis using high-flux membranes.
Control group
Active

Outcomes
Primary outcome [1] 238396 0
Mean annual change in neuropathy as measured by the Total Neuropathy Score
Timepoint [1] 238396 0
12, 24, 36 and 48 months after randomisation
Secondary outcome [1] 244858 0
Mean annual change in neuropathy as measured by the Neuropathy Symptom Score
Timepoint [1] 244858 0
12, 24, 36 and 48 months after randomisation
Secondary outcome [2] 244859 0
Safety as measured by:
a) Time to access failure, defined as thrombosis or fistula requiring revision
b) Number of discrete episodes of access failure, defined as above.
c) Episodes of septicaemia defined as blood culture positive septic episode with no defined focal source.
d) Difference in survival between the two groups
Timepoint [2] 244859 0
Continuous from baseline to 48 months after commencement of treatment. Survival will also be measured access to site Australia and New Zealand Dialyis and Transplant Registry (ANZDATA) data at 60 months.
Secondary outcome [3] 244860 0
Durability of the intervention (whether the patient remains on the assigned intervention)
Timepoint [3] 244860 0
Measured directly at 12, 24, 36 and 48 months after randomisation and at 60 months by site access to ANZDATA data.
Secondary outcome [4] 244861 0
Quality of life outcomes
Analyses will be performed in participants with sufficient language skills to self-complete a written questionnaire and will include:
a) Change in quality of life from baseline months as measured by the Kidney Disease Quality of Life (KDQOL-SF1.3) instrument
b) Change in quality of life from baseline as measured by the EurolQol (EQ-5D) instrument
Timepoint [4] 244861 0
6, 12, 18, 24, 30, 36, 42 and 48 months after randomisation

Eligibility
Key inclusion criteria
1. Incident or prevalent patients requiring maintenance haemodialysis therapy for end stage kidney disease.
2. Aged 18 years or older
3. Suitable for either haemodiafiltration or standard dialysis in the view of the treating physician
4. Agreeable to randomisation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if, in the opinion or knowledge of the responsible clinician:
1. Life expectancy is less than 6 months.
2. Definite plans to undergo renal transplantation, transfer to a non-study site, transfer to peritoneal dialysis or transfer to home haemodialysis within 12 months of entry to the study.
3. Unable or unwilling to complete neuropathy staging, including nerve conduction studies.
4. Receiving haemodiafiltration

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237347 0
Hospital
Name [1] 237347 0
Statewide Renal Services
Country [1] 237347 0
Australia
Primary sponsor type
Hospital
Name
Statewide Renal Services
Address
Department of Renal Medicine
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 236838 0
None
Name [1] 236838 0
Address [1] 236838 0
Country [1] 236838 0
Other collaborator category [1] 767 0
University
Name [1] 767 0
University of New South Wales
Address [1] 767 0
UNSW Kensington Campus
The University of New South Wales
Sydney NSW 2052
Country [1] 767 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239468 0
Ethics Review Committee (Royal Prince Alfred Hospital (RPAH) Zone) of the Sydney South West Area Health Service
Ethics committee address [1] 239468 0
Ethics committee country [1] 239468 0
Australia
Date submitted for ethics approval [1] 239468 0
09/06/2009
Approval date [1] 239468 0
27/07/2009
Ethics approval number [1] 239468 0
HREC/09/RPAH/268

Summary
Brief summary
The reduction in quality of life and illness burden experienced by people with end stage kidney disease (ESKD) is exacerbated by the condition of ‘uraemic neuropathy’. Uraemic neuropathy affects between 60 and 100% of people with ESKD and can lead to loss of function as well as discomfort or pain. It is progressive with no specific cures or methods of retarding progression other than transplantation.
The FINESSE study will compare the effect of haemodiafiltration and standard haemodialysis with high-flux membranes on the development and progression of uraemic neuropathy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29919 0
Address 29919 0
Country 29919 0
Phone 29919 0
Fax 29919 0
Email 29919 0
Contact person for public queries
Name 13166 0
Liz Haberecht
Address 13166 0
Statewide Renal Services
Building 12
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 13166 0
Australia
Phone 13166 0
+61 2 95153505
Fax 13166 0
+61 2 95153501
Email 13166 0
[email protected]
Contact person for scientific queries
Name 4094 0
Meg Jardine
Address 4094 0
Statewide Renal Services
Renal Unit
4W
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country 4094 0
Australia
Phone 4094 0
+61 2 97676447
Fax 4094 0
+61 2 97676254
Email 4094 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23156Statistical analysis plan    Available on The George Institute website

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of hemodiafiltration on the progression of neuropathy with kidney failure: A randomized controlled trial.2021https://dx.doi.org/10.2215/CJN.17151120
EmbaseRandomised controlled trial of the impact of haemodiafiltration on uraemic neuropathy: FINESSE study protocol.2019https://dx.doi.org/10.1136/bmjopen-2018-023736
N.B. These documents automatically identified may not have been verified by the study sponsor.